FDA WARNING_LETTER - Burgos Burgos Corp. - October 14, 2009

The FDA inspected Burgos Burgos Corporation dba The Sandwich Lady's seafood processing facility in Silver Spring, MD, on October 8, 13, and 14, 2009. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their tuna salad sandwiches adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for ready-to-eat tuna salad sandwiches to control pathogen growth and histamine formation, violating 21 CFR 123.6(a) and (b). 2. **Inadequate Sanitation Monitoring:** The firm did not adequately monitor sanitation conditions, specifically failing to prevent cross-contamination, as employees manufactured ready-to-eat tuna sandwiches without protective beard or mustache coverings, violating 21 CFR 123.11(b). 3. **Failure to Maintain Sanitation Records:** The firm did not maintain required sanitation monitoring records for various aspects, including water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, food protection, chemical handling, employee health, and pest control, violating 21 CFR 123.11(c).

The FDA warned